Walgreens countersued the DOJ lawsuit the same day, asking the court to clarify the requirements for pharmacists in dispensing controlled prescriptions while defending itself against the allegations.

“This lawsuit seeks to hold Walgreens accountable for the many years that it failed to meet its obligations when dispensing dangerous opioids and other drugs,” said Principal Deputy Assistant Attorney General Brian M. Boynton, head of the DOL’s Civil Division. “Our complaint alleges that Walgreens pharmacists filled millions of controlled substance prescriptions with clear red flags that indicated the prescriptions were highly likely to be unlawful, and that Walgreens systematically pressured its pharmacists to fill prescriptions, including controlled substance prescriptions, without taking the time needed to confirm their validity. These practices allowed millions of opioid pills and other controlled substances to flow illegally out of Walgreens stores.”

If Walgreens is found liable, it could face civil penalties of up to $80,850 for each unlawful prescription filled in violation of the CSA and applicable penalties for each prescription paid by federal programs in violation of the FCA.

From approximately August 2012 through the present, Walgreens knowingly filled millions of prescriptions for controlled substances that lacked a legitimate medical purpose, were not valid, and/or were not issued in the usual course of professional practice, according to the suit. Among the unlawful prescriptions that Walgreens allegedly filled were prescriptions for dangerous and excessive quantities of opioids, prescriptions for early refills of opioids and prescriptions for the especially dangerous combination of drugs known as the “trinity” – an opioid, a benzodiazepine and a muscle relaxant.

Walgreens allegedly ignored substantial evidence from multiple sources that its stores were dispensing unlawful prescriptions, including from its own pharmacists. Walgreens also allegedly deprived its pharmacists of crucial information, including by preventing pharmacists from warning one another about certain prescribers.

The complaint alleges that by knowingly filling unlawful prescriptions for controlled substances, Walgreens violated the CSA and, where Walgreens sought reimbursement from federal health care programs, also violated the FCA. The complaint alleges that Walgreens’ actions helped to fuel the prescription opioid crisis. “In some particularly tragic instances, patients died after overdosing on opioids shortly after filling invalid prescriptions at Walgreens,” read the lawsuit.

“Walgreens and its pharmacists have an obligation to ensure that every prescription they fill is legitimate and issued responsibly. As this lawsuit alleges, Walgreens failed in this obligation, and many times ignored the red flags that warned of suspicious prescribing practices,” said DEA Principal Deputy Administrator George Papadopoulos.

Similarly, CVS also allegedly filled large quantities of prescriptions for controlled substances written by prescribers it knew to be engaged in “pill mill practices” — that is, prescribers who issue large numbers of controlled substance prescriptions without any medical purpose. CVS ignored substantial evidence from multiple sources, including its own pharmacists, indicating that its stores were dispensing unlawful prescriptions, according to the DOJ complaint.

The CVS complaint alleges that its actions also helped to fuel the opioid crisis and that, in some particularly tragic instances, patients died after overdosing on opioids shortly after filling unlawful prescriptions at CVS. The complaint described 10 individual patients who died, allegedly after filling illegal prescriptions for opioids and other drugs at CVS.

Related: DOJ sues CVS, alleging pharmacy filled ‘unlawful’ prescriptions and contributed to opioid crisis

According to the Walgreens complaint, four different whistleblowers who previously worked for the pharmacy in various parts of the country filed whistleblower actions under the FCA, which permits the United States to intervene and take over such lawsuits, while private parties share in any recovery. The four cases have been consolidated under United States ex rel. Novak v. Walgreens Boots Alliance Inc.